BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    K Number: K070262 · Decision Mar 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    36
    Review Days
    47

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    Basic Information

    Device Name
    ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    K Number
    K070262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oxoid , Ltd.
    Date Received
    January 26, 2007
    Decision Date
    March 14, 2007
    Product Code
    JTN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTN Susceptibility Test Discs, Antimicrobial

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